European Union authorizes vaccine exports to Canada
OTTAWA - Prime Minister Justin Trudeau announced a tentative deal Tuesday with U.S. vaccine-maker Novavax to produce its product in Canada if the COVID-19 vaccine gets approved for use here.
“This is a major step forward to get vaccines made in Canada, for Canadians,” Trudeau said.
But the agreement won't ease pressure on the government to get vaccines into Canada because it won't start delivering until late next fall.
Novavax applied Friday for regulatory approval for its vaccine candidate in Canada but is still finishing its clinical trials and doesn't expect to have the final data available for a month at least. The NRC facility is going up at lightning speed, said Industry Minister Francois-Philippe Champagne, but it won't be finished until late summer.
And then it will take a month or two, said Champagne, for the facility to be certified.
“At the end of the year we will be a position to be producing vaccine,” said Champagne.
The new facility in Montreal was announced last August, and Champagne's department has been in talks with most of the leading vaccine makers trying to lure them into making their vaccine there when it is finished.
None of those talks bore fruit until now.
Currently Canada relies on Europe for its COVID-19 vaccine supply, a situation that's becoming treacherous because the European Union has new export controls on COVID-19 vaccines to try to protect its own deliveries.
Trudeau said the oral promises he received from European Commission President Ursula von der Leyen that Canada's deliveries won't be stopped by the new controls, “were enough” to reassure him.
This week's shipments of vaccines from Pfizer-BioNTech and Moderna are both starting to arrive in provincial receiving locations already, said Procurement Minister Anita Anand.
Canada's shipments have been delayed or reduced by production slowdowns, but Trudeau said the promised four million doses from Pfizer and two million from Moderna are still expected to arrive by the end of March, and 40 million from each by the fall.
If Canada's deliveries aren't interrupted, Canada's plan is to have most Canadians vaccinated by the end of September, before the new Canadian production of Novavax's product even starts.
Trudeau said Canada has to look beyond the current vaccine plan.
“We don't know what the future looks like for a year from now, two years from now, three years from now,” he said. “What we're very clear on is Canada will be developing domestic manufacturing.”
Both NDP Leader Jagmeet Singh and Conservative Leader Erin O'Toole said the Novavax deal is welcome but too late.
“This is something that should have been secured a long time ago,” said Singh. “It would have addressed a lot of the insecurity people are feeling about not getting the vaccine and seem delays in the rollout, because of production delays.”
O“Toole said the fact the deal won't help Canada for months underscores the glacial pace the Trudeau government has set in expanding Canada's domestic biomanufacturing industry.
“We need vaccines to turn the corner on COVID-19,” he said.
O'Toole said Canada should have learned the lessons last spring, when not having places to make face masks and respirators and surgical gowns left Canada to compete in a wild global marketplace to get them.
Now we're in the same position with vaccines, he said.
Canada used to have a strong domestic vaccine industry. Federal records show in 1973, Canada relied on imports for only about one-fifth of its domestic pharmaceutical requirements including both vaccines and therapeutic drugs.
But the industry began to dry up in the 1980s, with multiple firms closing their Canadian operations, including AstraZeneca, Bristol Myers and Johnson and Johnson.
Today, Canada relies on imports for at least 85 per cent of the vaccines and other pharmaceuticals it uses.
Novavax would be the first COVID-19 vaccine to be made in Canada. Medicago, the only potential Canadian supplier of the seven COVID-19 vaccines the federal government has pre-purchased, is building a new facility in Quebec to eventually make vaccines but if its COVID-19 vaccine safely finishes clinical trials and is approved, the initial doses will be made in North Carolina.
Sanofi and GlaxoSmithKline are partnering on a vaccine though it is delayed until at least the fall because of disappointing early results. GSK, which is supplying the adjuvant for the vaccine - an additive to increase its effects - may fill vials with the adjuvant in Canada but the vaccine itself will be produced by Sanofi elsewhere.
Trudeau announced two other new facilities will be capable of producing COVID-19 vaccines, but neither will be ready to do so this year.
The Vaccine and Infectious Disease Organization at the University of Saskatchewan will be able to produce 40 million doses annually but won't be finished until the end of 2021.
A new facility at Precision NanoSystems in Vancouver will be the first in Canada capable of producing mRNA vaccines, the technology involved in both vaccines from Pfizer-BioNTech and Moderna.
But that facility won't be ready until 2023, said Champagne.
Canada has a contract to buy 52 million doses from Novavax. Last week the company said a Phase 3 trial - typically the last before a product is approved for wide use - in the United Kingdom showed the vaccine to be 89 per cent effective against COVID-19, including the new variant known as B.1.17 that was first identified there. A smaller Phase 2 trial in South Africa showed the vaccine was also effective against a variant that first emerged there, known as B.1.351.
If it is approved by Health Canada, some doses will still have to be imported, because the new facility in Montreal is equipped to make only about two million doses a month.
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